China race for Covid-19 pill treatment hit by low hospital cases
- Late-stage clinical trials for Kintor Pharma’s experimental drug misses statistical criteria because of ‘changing conditions’ in US
- But analysis shows no safety concerns and no serious adverse events for the drug, which is being tested in several countries
“Statistical criteria were not met at an interim analysis of the phase 3 outpatient study,” the company announced on Monday night. However, the analysis did show there were no safety concerns and no serious adverse events reported which related to the drug, Kintor added.
The interim analysis involved 348 patients with mild-to-moderate Covid-19 symptoms from the US, where the hospitalisation rate is “very low”, the company said.
Kintor’s chairman and CEO Tong Youzhi said the results were related to the changed Covid-19 situation in the US.
Speaking to Chinese financial news site Yicai, he said vaccination had reduced the number of severe cases in the US and the treatment environment for patients with the illness was also improving. Patients are now younger, and young people fare better than the elderly with Covid-19, Tong said.
“When the rate of hospitalisation for Covid-19 has dropped to 2 or 3 per cent, it is very difficult for the drug to reduce this rate again, and a drug is supposed to further reduce the rate. It is very difficult for a small sample trial to reflect a statistical difference.”
The trial involved male and female patients with one or more mild Covid-19-related symptoms within five days of onset.
Participants were randomised to receive 200mg of Proxalutamide or a placebo twice daily for 14 days. The enrolment covered the whole population, including patients with a vaccination history, as well as without any risk factors.
The primary endpoint was the percentage of all-cause deaths and hospitalisations for a period exceeding 24 hours by day 28.
Kintor will seek approval from drug regulators, including the US Food and Drug Administration, to amend the protocol and continue to enrol higher risk Covid-19 patients in further trials, the company said.
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Participants should have multiple co-morbidities and/or can be unvaccinated for Covid-19.
A small-molecular pill developed by Merck and approved for emergency use in the US was tested on outpatients who were unvaccinated and had at least one risk factor associated with poor disease outcomes, such as heart disease and diabetes.
A Pfizer pill, which has also been approved for emergency use in the US, was tested on patients with at least one underlying medical condition associated with an increased risk of developing severe illness from Covid-19.
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“The Covid-19 pandemic continues to evolve with the Omicron variant highlighting the need for therapeutics,” Tong said.
“It is important to investigate new modalities to treat those infected with the virus. We believe Proxalutamide could become an important tool in the fight against Covid-19 infection and will continue to investigate its use.”
Tong told investors in a telephone meeting on Tuesday morning that the company would provide the drug to all countries for free, for compassionate use in treating mild and severe illness, according to online news site Thepaper.cn.
China has already approved its first Covid-19 treatment – an antibody cocktail developed by Brii Biosciences – but it needs to be administered intravenously.
